Sporanox and Lamisil for the Treatment of Onychomycosis
Sporanox and Lamisil
Public Health Advisory
The FDA issued a Public Health Advisory to announce important safety-related updates to the labeling of Sporanox® (itraconazole) and Lamisil® (terbinafine hydrochloride) Tablets.
FDA is advising healthcare professionals not to prescribe Sporanox® to treat fungal infections (onychomycosis) in patients who have congestive heart failure (CHF) or a history of CHF. The updated Sporanox® labeling also includes contraindications and precautions with certain medicines.
FDA Public Health Advisory (5/9/2001)
Questions and Answers (5/9/2001)
Letter to Health Care Professionals-Lamisil (Medwatch) (5/11/2001)
Letter to Health Professionals-Sporanox (Medwatch) (5/9/2001)
Revised Labeling - Sporanox Capsules (5/9/2001)
Revised Labeling - Lamisil Tablets (5/9/2001)